Proportion of subjects with ≥ 50% reduction in a cluster of PV-related symptoms, measured using a patient questionnaire, at week 16 compared to Baseline. [ Time Frame: Baseline and Week 16. ] [ Designated as safety issue: No ]

The purpose of the RELIEF study is to compare symptoms in polycythemia vera (PV) subjects treated with ruxolitinib versus subjects treated with hydroxyurea (HU) as measured by the percent of subjects who achieve a clinically meaningful symptom improvement (ie, total symptom score reduction of ≥ 50% reduction) at Week 16 compared to Baseline. The study is also designed to demonstrate that these responses are durable with continued treatment.

Detailed Description

This is a Phase 3 multicenter, double-blind, double-dummy, randomized study. Only subjects with PV who have received HU for at least 12 weeks, have been receiving a stable dose before screening and still have symptoms related to PV will be enrolled.

Subjects will be randomized (1:1) to 1 of 2 treatment arms:

A: ruxolitinib and HU-placebo B: HU and ruxolitinib-placebo

Subjects randomized to either arm may be eligible to transition to open-label ruxolitinib after Week 16.

Ruxolitinib will be self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day by mouth. Doses increases of 5 mg (1 tablet) in twice daily increments are permitted after 4 weeks and again after 8 weeks of therapy.

Drug: hydroxyurea (HU)

Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting pre-specified criteria.

Drug: placebo

All placebo will be self-administered and dosing will the same as with the blinded dose and comparator arm.

Study Arm (s)

Experimental: ruxolitinib and hydroxyurea (HU)-placebo

Interventions:

Drug: ruxolitinib

Drug: placebo

Active Comparator: HU and ruxolitinib-placebo

Interventions:

Drug: hydroxyurea (HU)

Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

110

Completion Date

November 2014

Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Subjects must currently be reporting symptoms while on a stable dose of HU monotherapy and be eligible to continue HU on study after randomization.

Before screening, the subject must have been receiving HU for at least 12 weeks AND be receiving a stable dose.

Subjects must meet baseline symptom criteria

Subjects should meet at least 1 of the following criteria:

No more than 1 phlebotomy within the 6 months before screening OR

No palpable splenomegaly.

Subjects must have a hematocrit that can be controlled within 35% to 48% (inclusive) before randomization.

Exclusion Criteria:

Subjects with inadequate liver or renal function at screening.

Subjects with clinically significant infection that requires therapy

Subjects with known active hepatitis A, B, or C at screening or with known HIV positivity.